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| ID | Type | Description | Link |
|---|---|---|---|
| C41213GM | Other Grant/Funding Number | NYSCIRB NY State Department of Health | |
| 1349754 | Other Grant/Funding Number | Craig H. Neilsen Foundation |
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| Name | Class |
|---|---|
| Bronx Veterans Medical Research Foundation, Inc | OTHER |
| Kessler Institute for Rehabilitation | INDUSTRY |
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The purpose of this research study is to measure the tolerability and preliminary efficacy of a drug, galantamine, to treat metabolic syndrome (MetS) by reducing circulating inflammation in people with spinal cord injury (SCI). Galantamine is FDA-approved for the treatment of Alzheimer's disease. Here, the drug is considered experimental for the purposes of this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Galantamine ER | Experimental | All participants (tetraplegia and paraplegia cohorts) receive galantamine hydrobromide extended release (ER) capsules. Aim 1 (Day 1): single 8mg dose administered orally in the laboratory with at least 5 hours of monitored observation. Aim 2 (Weeks 1-12): 8mg once daily for Weeks 1-4, with dose escalation to 16mg (two 8mg capsules) once daily for Weeks 5-12 based on tolerability. Taken orally in the morning with a meal. The two cohorts (tetraplegia and paraplegia) are analyzed separately as pre-specified subgroups. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galantamine Hydrobromide Extended Release | Drug | Galantamine hydrobromide extended release (ER) capsules, 8mg, administered orally once daily in the morning with a meal. Aim 1: Single 8mg dose in the laboratory with at least 5 hours of observation. Aim 2: 8mg once daily for Weeks 1-4; dose escalated to 16mg once daily (two 8mg capsules) for Weeks 5-12 based on tolerability. If the 16mg dose is not tolerated, the participant returns to 8mg daily. Total treatment duration: 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ISCI-BDS Neurogenic Bowel Symptoms Score (Aim 1 and Aim 2) | Neurogenic bowel symptoms assessed using the International SCI Bowel Function Data Set (ISCI-BDS). Worsening will be defined as a negative change in ISCI-BDS score category (e.g., mild to moderate). | Visit 0 (Screening) through Visit 5 (Week 12) |
| Change in Heart Rate (Avg) During In-Lab Observation (Aim 1) | Heart rate (beats per minute) measured before administration of galantamine 8mgER and at 15-minute intervals during the in-lab observation period. | Visit 1 (Day 1; pre-dose through 5 hours post-dose) |
| Change in Blood Pressure During In-Lab Observation (Aim 1) | Blood pressure (mmHg) measured in the seated position before administration of galantamine 8mgER and at 15-minute intervals during the in-lab observation period. | Visit 1 (Day 1; pre-dose through 5 hours post-dose) |
| Occurrence of Adverse Events During In-Lab Observation (Aim 1) | Frequency and severity of all adverse events (AEs) during the in-lab observation period after a single dose of galantamine 8mgER, assessed by standardized AE survey and open-ended questions. AEs are graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The number of participants experiencing at least one AE will be reported. | Visit 1 (Day 1; pre-dose through 5 hours post-dose) |
| Change in Heart Rate (Avg) During Outpatient Treatment (Aim 2) | Heart rate (beats per minute) measured at each study visit and daily at home. | Visit 2 (Day 2) through Visit 5 (Week 12) |
| Change in Blood Pressure During Outpatient Treatment (Aim 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Inflammatory Cytokines During Outpatient Treatment (Aim 2) | Inflammatory markers such as: TNF-α, IL-1ß, IL-6, IL-10, and other cytokines (pg/ml) will be measured in plasma at Visit 2 (Day 2) and Visit 5 (Week 12) | Visit 2 (Day 2) and Visit 5 (Week 12) |
| Change in Plasma Leptin During Outpatient Treatment (Aim 2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ona Bloom, PhD | Contact | 516-562-1309 | obloom@northwell.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kessler Institute for Rehabilitation | Not yet recruiting | West Orange | New Jersey | 07052 | United States |
All data must be de-identified in accordance with institutional, local, state, and federal guidelines.
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This is an exploratory, three-site, parallel group, open-label study to evaluate tolerability and preliminary efficacy of galantamine to treat MetS via reduction of systemic inflammation in people with chronic SCI (tetraplegia or paraplegia). Participants with tetraplegia or paraplegia will be analyzed separately as independent groups.
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Blood pressure (mmHg) will be measured at each study visit and daily at home |
| Visit 2 (Day 2) through Visit 5 (Week 12) |
| Occurrence of Adverse Events During Outpatient Treatment (Aim 2) | Frequency and severity of all adverse events (AEs) during the 12-week outpatient dose escalation period, assessed at each study visit and via weekly phone calls. AEs are graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 by severity and relationship to study drug. The number of participants experiencing at least one AE will be reported. | Visit 2 (Day 2) through Visit 5 (Week 12) |
Plasma leptin levels measured (pg/ml) at Visit 2 (Day 2) and Visit 5 (Week 12) |
| Visit 2 (Day 2) and Visit 5 (Week 12) |
| Change in Plasma Adiponectin During Outpatient Treatment (Aim 2) | Plasma adiponectin levels (µg/mL) measured at Visit 2 (Day 2) and Visit 5 (Week 12) | Visit 2 (Day 2) and Visit 5 (Week 12) |
| Change in Lipids (HDL, LDL, and Triglycerides) | High-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides (mg/dL) will be measured at Visit 0 (Screening) and Visit 5 (Week 12) | Visit 0 (Screening) and Visit 5 (Week 12) |
| Change in Fasting Plasma Insulin | Fasting plasma insulin levels (µIU/mL) measured at Visit 0 (Screening) and Visit 5 (Week 12) | Visit 0 (Screening) and Visit 5 (Week 12) |
| Change in Fasting Blood Glucose | Fasting blood glucose levels (mg/dL) measured at Visit 0 (Screening) and Visit 5 (Week 12) | Visit 0 (Screening) and Visit 5 (Week 12) |
| Change in HOMA-IR From Screening (Aim 2) | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) calculated from fasting glucose and fasting insulin (Unitless index ) at Visit 0 (Screening) and Visit 5 (Week 12) | Visit 0 (Screening) and Visit 5 (Week 12) |
| Change in HbA1c From Screening | Hemoglobin A1c (HbA1c) levels (%) measured at Visit 0 (Screening) and Visit 5 (Week 12) | Visit 0 (Screening) and Visit 5 (Week 12) |
| Change in C-Reactive Protein (CRP) | C-reactive protein (CRP) levels (mg/L ) measured at Visit 0 (Screening) and Visit 5 (Week 12) | Visit 0 (Screening) and Visit 5 (Week 12) |
| Change in Body Composition by DXA During Outpatient Treatment (Aim 2) | Total body fat mass (kg) and total body fat percentage measured by dual-energy X-ray absorptiometry (DXA) total body scan at Visit 2 (Day 2) and Visit 5 (Week 12) | Visit 2 (Day 2) and Visit 5 (Week 12) |
| Change in Waist and Hip Circumference During Outpatient Treatment (Aim 2) | Waist and Hip circumference (cm) measured by tape measure at Day 2 and at Week 12. | Visit 2 (Day 2) and Visit 5 (Week 12) |
| Change in High Frequency Heart Rate Variability (HF-HRV) During Outpatient Treatment (Aim 2) | High frequency component of heart rate variability (HF-HRV), a valid estimate of cardio-vagal tone (ms²) measured during supine and seated observations Visit 2 (Day 2), Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12) | Visit 2 (Day 2), Visit 3 (Week 4), Visit 4 (Week 8), and Visit 5 (Week 12) |
| Northwell Health | Recruiting | Manhasset | New York | 11030 | United States |
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| James J. Peters VA Medical Center | Recruiting | The Bronx | New York | 10468 | United States |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D010264 | Paraplegia |
| D011782 | Quadriplegia |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005702 | Galantamine |
| ID | Term |
|---|---|
| D047151 | Amaryllidaceae Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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